Kornimate/medical-research-clean huggingface dataset:
long-term safety and efficacy of hb0034 in subjects with generalized pustular psoriasis

Conditions: Generalized Pustular Psoriasis

Summary: this is a phase iib, long term extension study to evaluate the safety and efficacy of hb0034 in adult subjects with generalized pustular psoriasis (gpp).

this study will also evaluate the pharmacokinetic (pk) profile of hb0034 and explore the immunogenicity of hb0034 in subjects with gpp

Eligibility criteria:
inclusion criteria: * patients participated in the preceding placebo-controlled phase 2 study （hb0034-04）and completed at least the week 12 visit of the hb0034-04 study * subject must be a candidate for prolonged gpp treatment according to the investigator's judgment * men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug; * patients who fully understand and voluntarily sign an icf, and are willing and able to follow clinical study and subsequent visit schedules exclusion criteria: * patients who are experiencing gpp flare
sorafenib with biib022 in hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: this is a phase 1b, open-label study of sorafenib with biib022 in subjects with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * age ≥18 years * histologically-confirmed advanced hcc with at least 1 target lesion measurable by modified recist. * child-pugh score a5 or a6. * ecog performance status of ≤2. exclusion criteria: * known central nervous system or brain metastases. * prior anti-igf-1r therapy. * prior systemic therapy for advanced hcc. prior local therapies are only permitted if subjects have documented disease progression according to modified recist. * concurrent anticancer therapy. * history of myocardial infarction within 12 months prior to day 1 or chronic heart failure. * acute hepatitis * fibrolamellar hcc other protocol-defined inclusion/exclusion criteria may apply

Keywords: liver cancer hepatocellular carcinoma sorafenib hcc biib022 open-label igf-1r nexavar
4-week seaweed supplementation on menopause symptoms and psychological wellbeing

Conditions: Menopausal Syndrome; Menopausal Depression

Summary: menopausal symptoms have a substantial effect on quality of life as well as potentially serving as markers for future health. previous research has suggested that diet can impact menopausal symptoms. seaweed is marketed as a treatment to alleviate menopause symptoms, but no research has tested whether it is effective in reducing the symptoms and psychological effects associated with menopause. the aim of this study is to investigate the effects of consuming a seaweed supplement over a 4-week time period on menopausal symptoms and psychological well-being.

menopause and peri-menopause are associated with a number of symptoms and psychological well-being. previous literature has found a relationship between diet and menopause management. for example, following the mediterranean diet consuming a variety of vegetables, fruits, legumes and whole grains has found to improve menopausal symptoms particularly vasomotor symptoms. few studies have explored the effects of dietary supplements on psychological well-being in menopause. the aim of the study is to explore the impact of an iodine-rich seaweed food supplement on menopause symptoms and mental well-being in those experiencing menopause. online assessments of symptoms will take place pre-intervention and post-intervention and will be compared to the effects of a placebo.

Eligibility criteria:
inclusion criteria: * self-assess as healthy * experienced menopausal or peri-menopausal symptoms in the past 6 months exclusion criteria: * are currently taking hrt, anti-depressants, or anti-anxiety medication * are lactating or pregnant (or seeking to become pregnant) * have a thyroid disorder * are currently taking iodine supplements * have any relevant food intolerances
study of single doses of sbt777101 in subjects with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: this study will test the safety and effects of sbt777101 when given as a single dose to subjects with hidradenitis suppurativa. increasing dose levels will be given after the safety at lower dose levels is shown.

the study evaluates the safety and effects of a novel regulatory cartreg cell-based autoimmune and inflammatory disease therapy for the treatment of hidradenitis suppurativa. the therapy is an autologous (using the patient's own cells) treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≤50 kg/m2, inclusive * diagnosis of clinically active moderate-to-severe hs (hurley stage 2 or 3) * total abscess or inflammatory nodule (an) count of ≥5, affecting at least 2 distinct anatomic regions, with at least 1 accessible an of adequate size for biopsy (diameter \> 1 cm) * total draining tunnel (dt) count of ≤20 * documented history of inadequate response or intolerance to at least a 3-month course of 1 conventional systemic therapy (e.g., antibiotic) and 1 biologic drug (e.g., adalimumab or secukinumab) * doses of medications for hs must be stable for at least 5 weeks prior to study drug administration * must agree to use highly effective method of contraception for at least 1 year post sbt777101 administration exclusion criteria: * major surgery within 12 weeks prior to screening or planned within 12 months after dosing * history of or current inflammatory or other autoimmune disease * complex presentations of hs * skin disease other than hs that may confound clinical assessments or increase subject risk in the study * uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease * active current infection or history of recurrent infections * active or untreated latent tuberculosis * primary or secondary immunodeficiency

Keywords: regulatory t cells car t treg autologous cell therapy hidradenitis suppurativa autoimmune disease inflammatory disease
rescue fmt with bezlotoxumab for recurrent c. difficile infection

Conditions: Recurrent C. Difficile Infection

Summary: the goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (fmt) in patients with recurrent clostridioides difficile infections after failure of fmt alone.

initial failure of fmt in breaking the cycle of recurrent c. difficile infections is associated with a greater risk of subsequent failure. previous analysis showed that fmt failure is associated with delayed repair of fecal microbiota at one week after administration. the hypothesis underlying this trial is that increased symptom-free interval by administration of bezlotoxumab can improve the outcomes of a second fmt.

Eligibility criteria:
inclusion criteria: 1. informed consent. 2. diagnosis of recurrent c. difficile infection based on symptoms and laboratory confirmation. 3. failure of standard antibiotic therapies prior to the initial fmt exclusion criteria: 1. pregnancy. 2. class iii or above heart failure.
vitamin d and glucose metabolism in pediatrics

Conditions: Insulin Resistance; Obesity; Vitamin D25 Insufficiency

Summary: the discovery that the vitamin d receptor is expressed in more than 30 tissues indicates that the physiologic functions of vitamin d are much broader than its well-known role in the regulation of calcium absorption and bone metabolism. there is evidence that vitamin d is involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type i diabetes. recent epidemiological evidence points to a strong association between vitamin d insufficiency and insulin resistance, the metabolic syndrome, and type ii diabetes. the investigators would like to examine the role of vitamin d in the development of insulin resistance in overweight children and adolescents, which represent a high risk population for cardiovascular and metabolic complications. the investigators propose a prospective randomized clinical trial of vitamin d supplementation in overweight, insulin resistant, vitamin d deficient children. the investigators objective is to assess if changes in insulin resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these patients post treatment with vitamin d. additionally, concomitant changes in calcium and bone metabolism after vitamin d treatment will be evaluated. this is because, contrary to adults, the optimal vitamin d concentrations that regulate calcium and bone metabolism have not been established in pediatrics.


Eligibility criteria:
inclusion criteria: 1. bmi\>85th% for age \& sex 2. vitamin d25 between 10-20ng/ml 3. normal serum ca concentrations \>8.5mg/dl 4. evidence of insulin resistance (measured by homa-ir, and quicki indices) exclusion criteria: 1. vitamin d25\<10ng/ml 2. no parental consent 3. no evidence of insulin resistance 4. bmi \< 85th percentile 5. known diagnosis of type 1 or 2 diabetes 6. severe underlying disease such as liver disease, end-stage renal disease, or malignancy 7. present medication that affects insulin sensitivity such as steroids or metformin 8. any chronic illness or administration of medications that is associated with fat malabsorption as they may interfere with vitamin d absorption. 9. known history of hypocalcemia, calcium disorder (such as di george syndrome) 10. serum calcium concentration \< 8.5mg/dl 11. other drugs that might effect vitamin d metabolism due to induction of p450 enzyme activity.

Keywords: insulin resistance obesity adolescence vitamin d supplementation
the use of tranexamic acid to reduce perioperative blood loss during high risk spine fusion surgery

Conditions: Curvature of Spine

Summary: the purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.

there are conflicting studies in the literature reporting different efficacy outcomes for the use of antifibrinolytics in spine fusion surgery. several studies support the successful use of tranexamic acid for major orthopedic procedures, but the patient populations studied for spine surgery thus far have been small and highly variable, with less than clinically significant results. if txa if efficacious in reducing not only perioperative blood loss, but rbc transfusion without an increase in thromboembolic events, then its use may be justified for patients at risk for major blood transfusion.

Eligibility criteria:
inclusion criteria: * age\>17 years * undergoing posterior spine fusion surgery for kyphoscoliosis with a \>80% chance of major transfusion exclusion criteria: * age \< 18 years * non-english speaking * pregnancy * emergency procedures * surgery for tumor, trauma or infection * severe coronary artery disease * history of venous thromboembolism * history of cerebral vascular accident * history of renal insufficiency * allergy to tranexamic acid
evaluation of synthesized 18-lead ecg in the emergency department

Conditions: Chest Pain

Summary: this study, sponsored by nihon kohden, aims to determine the sensitivity and specificity of synthesized 18-lead electrocardiogram (ecg) in the diagnosis of posterior-lateral and/or right-ventricular ischemia, using actual 18-lead ecg as the gold standard. the synthesized 18-lead ecg calculates six extra leads of information from the standard 12-lead ecg done in the emergency department (ed). nihon kohden has created syneci18 technology, which can mathematically synthesize and display the extra leads. the patient population (n=300) will consist of patients who present to the north shore university hospital or long island jewish medical center ed with a chief complaint of chest pain, chest pressure, or chest discomfort. these patients will be receiving a standard 12-lead ecg as part of their routine clinical care. patients with st-elevation myocardial infarction (stemi) and a known positive troponin value will be excluded from the study. trained ed study technicians will use ecg machines provided by nihon kohden to obtain two consecutive 15-lead ecgs. the two 15-lead ecgs are then saved onto the ecg machine.the saved information will later be input into an algorithm to calculate the synthesized 18-leads. the actual 18-leads (composed of the two 15-leads conducted in the ed) will be compared with the synthesized 18-leads produced by the syneci18 technology. a study cardiologists will evaluate the actual 18-lead ecgs and synthesized 18-lead ecgs and determine whether there is posterior-lateral and/or right-sided ventricular ischemia. the cardiologists will be blinded to the type of waveform they are analyzing (synthesized versus actual). the study will not interfere with patient care or treatment, however, the two 15-lead ecgs done in the ed will be shown to the physician who can determine whether or not to order an official 18-lead ecg in the hospital's electronic medical record system. it is hypothesized that the syneci18 synthesized 18-lead ecgs will provide high sensitivity and specificity for diagnosing posterior-lateral and/or right-ventricular ischemia, with the actual 18-lead ecgs being used as the reference for comparison.


Eligibility criteria:
inclusion criteria: * subjects with a chief complaint of chest pain or chest discomfort or chest pressure * troponin test has been ordered (unknown positive at time of recruitment) * subjects are capable of providing informed consent * english speaking exclusion criteria: * stemi patients * patients who have not had a troponin test ordered * pregnant women * patients under 18 years of age * prisoners
circulating tumor dna guided boost therapy in early triple negative breast patients with residual disease after neoadjuvant therapy

Conditions: Breast Cancer

Summary: early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctdna effectively identified patients with highest relapse risk. this trial aims to explore whether the combination of anlotinib, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.


Eligibility criteria:
inclusion criteria: * stage ii-iii breast cancer patients, excluding occult breast cancer, inflammatory breast cancer, metaplasia breast cancer * tnbc patients. tnbc was defined as er \<= 10%, pr \<=10%, her 0-1, or her2 2+ and fish negative. exclusion criteria: -
single incision laparoscopic surgery (sils) versus laparoscopic appendectomy

Conditions: Appendicitis

Summary: this is a prospective trial of single incision versus standard 3-port laparoscopic appendectomy. the hypothesis is that there may a difference in wound infection rates, operative time, doses of analgesics post-operatively, and patient/parent perception of scars.

this is a prospective, randomized clinical trial involving patients who present to the hospital with non-perforated appendicitis. we will offer enrollment to several institutions provided they receive institutional approval. there are likely several parameters that will show small differences between groups, and this study will precisely quantify them to allow for adequate consultation from surgeons to families dealing with acute appendicitis. one theoretical concern over the sils approach is that the exposure of the appendix to the wound could increase the rate of infectious complications; therefore, this is the primary outcome variable. the documented rate of infectious complications at our institution in patients with non-perforated appendicitis is 0.6%. an unacceptable and clinically relevant rise to 5% may curtail enthusiasm for the new technique. using a power of 0.9 with an α of 0.05, the sample size is 360 total patients or 180 in each arm. after the procedure, both groups will be managed in the same manner per routine care. they will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication. cosmetic scores will be obtained at 6 weeks and 6 months.

Eligibility criteria:
inclusion criteria: * children under 18 years * non-perforated appendicitis exclusion criteria: * perforated appendicitis as identified as a hole in the appendix for fecalith in the abdomen

Keywords: appendicitis appendectomy children laparoscopic sils
outpatient versus inpatient surgery for ankle fractures

Conditions: Ankle Fractures; Orthopedic Procedures; Surgical Procedures; Inpatient

Summary: this study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

this study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment. primary outcome: the primary objective of this study is to compare the 12-weeks patient reported foot and ankle outcome score (foas). secondary outcomes: multiple other analysis are planned, but being secondary, they are hypothesis generating. they will include, but are not limited to, cross-over, unscheduled contacts, adverse events, pain, general health, time to return to work and socio-economic consequences between the two groups.

Eligibility criteria:
inclusion criteria: * ankle fracture indicating surgical treatment. * fracture stable in lower leg cast. * patient 18 years or older. * patient is able to ambulate with walking aid, and perform adl at home. exclusion criteria: * impaired physical, mental or social capacity incapable of participating in study. * incapable of reading or understanding danish. * patient does not wich to participate. * concurrent major fracture to lower extremity (ipsi- and/or contralateral) * patholocigal fracture * asa score 3 or higher. * pregnancy. * open fracture. * infectious disease requiring isolation.
effect of strength and conditioning training on functional performance in children with chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: despite the benefits of physical rehabilitation among adults and children with chronic illness, they avoid to engage in different physical activities especially pediatric population. most of the children with chronic kidney disease receive their medical treatment and follow-up with no change of their functional performance. we still lack the evidence of plyometric exercises in pediatric population with chronic kidney disease . therefore, the primary aim of this study is to explore the effects of strength and conditioning training in the form of plyometric exercises on balance and muscle strength in children with chronic kidney disease .


Eligibility criteria:
inclusion criteria: * age will be ranged from 6-10 years. * both genders were included. * can follow instructions. * medically stable sedentary children with ckd, gfr (stage 2 (mild) egfr of 60-89 ml/min per 1.73 m2, stage 3 (moderate) egfr 30-59 ml/min per 1.73 m2) stage 4 (severe) egfr of 15-29 ml/min per 1.73 m2. * did not yet require renal replacement therapy (non-dialysis). exclusion criteria: * recent myocardial infarction, uncontrolled hypertension, unstable angina, symptomatic left ventricular fibrillation. * severe uncontrolled diabetes, * neurological or cognitive disorders * peripheral vascular disease.

Keywords: chronic kidney diseases plyometric exercises muscle strength balance
protection during cardiac surgery.

Conditions: Thoracic Surgery; Cardiopulmonary Bypass

Summary: this trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. the primary endpoint is the auc (area under the curve) of the hypersensitive troponin i. blood samples will be collected during the 72 hours following the aortic cross-unclamping. this trial is a french, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * aortic valve surgery (aortic valve replacement associated or not with coronary artery bypass graft, bentall surgery or tirone david surgery) * signed informed consent exclusion criteria: * emergency surgery * redo surgery * patient treated with nicorandil, repaglinid or sulfonylurea 48 hours prior to surgery * low cardiac output requiring catecholamine infusion or circulatory assistance prior to surgery * severe renal failure: dialysis or glomerular filtration rate \< 30 ml/min * severe liver failure (spontaneous inr \>2) * severe respiratory insufficiency (vems \<40% of predicted value) * contra-indication to sevoflurane and propofol * myocardial infarction \< 7 days * severe upper limb arterial disease * heparin-induced thrombopenia * active infection under antibiotic treatment * any other surgery combined with the aortic valve surgery: myotomia of morrow (hypertrophic myocardiopathy), treatment of heart rhythm disorder, inter-atrial communication closure, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement. * pregnant women * currently participating in another trial which may interfere with proccard results * not benefiting from a social insurance or similar system * patient under legal protection

Keywords: myocardial injury ischemia reperfusion cardiac surgery cardioprotection
efficacy of psychotherapy for depressed parkinson's disease patients

Conditions: Depression; Parkinson's Disease

Summary: the primary aim of this randomized controlled trial is to determine the acute antidepressant efficacy of interpersonal psychotherapy (ipt) in depressed patients with parkinson's disease.

the primary aim of this study is to determine whether ipt is more efficacious than an intervention that controls for non-specific factors (i.e., supportive psychotherapy) in reducing depressive symptoms. a secondary aim is to determine whether ipt is better than supportive therapy in improving quality of life, interpersonal functioning, attachment patters, and motor symptoms, and whether treatment gains are durable at 6-months follow-up. an exploratory aim of the study is identify moderators and mediators of treatment outcome. patients who meet study criteria will be randomly assigned to either 12 sessions of ipt or 12 sessions of supportive therapy. the primary efficacy measure (hamilton depression rating scale) will be administered at baseline, weeks 6 and 12, and at 6 months follow-up.

Eligibility criteria:
inclusion criteria: * outpatients with idiopathic parkinson's disease and between stages 1 and 3 in the modified hohn \& yahr clinical staging scale * diagnosis of a depressive disorder * score ≥ 12 on the 17-item hamilton depression rating scale * living independently exclusion criteria: * history of bipolar disorder or psychotic symptoms (other than drug induced) * substance-related disorders in the last 12 months * acutely suicidal or history of suicide attempts in the past 5 years * presence of cognitive deficits (i.e., score ≤ 24 on the mini mental status exam) or history of significant cognitive disorders * presence of other significant neurological problems * presence of unstable comorbid medical conditions * currently receiving psychotherapy * unable to attend weekly therapy sessions